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FDA approves Sandoz’s two denosumab biosimilars
2024-03-06
上市批准孤儿药细胞疗法免疫疗法
The FDA approval positions Wyost as a treatment to prevent skeletal-related events. Credit: BigPixel Photo / Shutterstock.com.
These bFood and Drug Administration (FDA) all indicatioSandozSandoztheWyostfedenosumab-bbdzs.Jubbontidenosumab-bbdzdenosumab
With a concentration of 120mg/1.7mL (70mg/mL), Wyost is indicated as interchangeable with its reference medicine, a human monoclonal antibody that acts on the RANKL protein, which is essential for the activation of osteoclasts.
This approval positions Wyost as a treatment toWyostent skeletal-related events in patients with multiple myeloma and for those with bone metastases caused by RANKL protein.
Wyost is also sanctionedWyostuse in adults and skeletally mature adolescents with giant cell tumomultiple myeloma are either unresectbone metastasesurgical ressolid tumourscause significant morbidity.
Wyostlso:A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancergiant cell tumours
FDA doublA2 Bion on patient engagemenFDAo support rare disease rcolorectal cancer
It is also approved for treating hypercalcaemia of malignancy resistant to bisphosphonate treatment.
FDAbonti is indicated to address several conditions related to bone health.
It is approved for treating high fracture risk in postmenopausal women with osteoporosis, for improving bone mass in men with osteoporosis at similar risk, and for managing glucocorticoid-induced osteoporosis in anyone with this risk.
Jubbonti is also approved to augmhypercalcaemia of malignancy fracture risk due to undergoing androgen deprivation treatment for non-metastatic prostate cancer, and women receiving adjuvant aromatase inhibitor therapy for breast cancer.
Jubbontie clinical studies support the latest regulatory approval in the US for these biosimilars and include safety warnings within the labelling.
The approval of Jubbonti is pairefracturehe sanctioning of Sandoz’s Jubbontiosteoporosistion and Mitigation Strategy (REMS) prosteoporosisglucocorticoid-induced osteoporosis
Jubbontiramme is tailored to educate prescribers and patients about potential severe hypocalcaemia risk, particularly in those winon-metastatic prostate cancerease, including those dependentaromatasesis.breast cancer
Sandoz North America president Keren Haruvi stated: “Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events […] disease states that can profoundly reduce the quality of life for patients.”
The latest development comes after Sandoz acquired US biosiSandozCIMERLI from Coherus BioSciences.
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